Phase
Condition
Heart Failure
Congestive Heart Failure
Williams Syndrome
Treatment
Gradient Denervation System
Clinical Study ID
Ages 22-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest
Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive legraise
NYHA Class II or III
Glomerular Filtration Rate (GFR) ≥ 25 ml/min
Exclusion
Exclusion Criteria:
Unwilling to provide informed consent or complete follow-up assessments
Life expectancy of < 2 years
Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergyto aspirin or clopidogrel
Unable to tolerate right heart catheterization
Severe aortic, mitral or pulmonary valve regurgitation
Clot or Thrombus in any potential target ablation zone (right, left or mainpulmonary artery)
Systemic infection or localized infection/rash at planned access site at time ofprocedure
CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) withinthe last 3 months
Study Design
Study Description
Connect with a study center
Hospital Clínico Universitario de Valencia
Valencia,
SpainActive - Recruiting
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